Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
Kardigan, Inc. · NCT07001800
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2, Phase 3
- Target enrollment
- 1276
- US sites recruiting
- 47
- Study start
- June 27, 2025
- Record last updated
- July 6, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Being studied: Ataciguat; Placebo
Conditions: Moderate Aortic Valve Stenosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key Inclusion Criteria
- Adult male or female at least 50 years of age
- Has moderate CAVS as defined by:
- An AVA of ≥1.0 cm2 to ≤1.50 cm2
- An AVC score between >300 to 1200 Agatston units (AU) for women and between >300 to 2000 AU for men
- Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
- For participants in CPET sub-study in Part A and all participants in Part B: If on beta blockade, the dose must be stable for at least 90 days prior to the Screening Visit with no anticipated changes during the study
Key Exclusion Criteria
- For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's opinion, could lead to an inability to complete Protocol-required CPET procedures (eg, pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
- Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
- Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- Has suspected or known congenital aortic valve disease including bicuspid aortic valve
- New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
- Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
- Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
- Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation
Recruiting US locations
University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, AL 35233
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Heart Center Research LLC
Huntsville, AL 35801
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
National Heart Institute
Beverly Hills, CA 90211
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Hoag Memorial Hospital Presbyterian
Newport Beach, CA 92663
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Profound Research LLC at Southern California Heart Specialists
Pasadena, CA 91105
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
University of California, San Francisco (UCSF) - Medical Center
San Francisco, CA 94143
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, CA 90502
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
HCA Florida - JFK Hospital
Atlantis, FL 33462
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
New Generation of Medical Research
Hialeah, FL 33016
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Jacksonville Center for Clinical Research
Jacksonville, FL 32216
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
New Generation of Medical Research - Naples
Naples, FL 34116
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Flourish Research - St. Augustine
Saint Augustine, FL 32086
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Sarasota Memorial Hospital
Sarasota, FL 34239
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
University of South Florida
Tampa, FL 33606
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Northwestern University The Feinberg School of Medicine
Chicago, IL 60611
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Ascension Heart and Vascular/Alexian Brothers Heart & Vascular Institute
Elk Grove Village, IL 60007
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
NorthShore University Health System
Glenview, IL 60026
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Midwest Cardiovascular Institute
Naperville, IL 60540
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Methodist Medical Center of Illinois
Peoria, IL 61636
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Midwest Cardiovascular Research and Education Foundation
Elkhart, IN 46514
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
University of Louisville Health
Louisville, KY 40202
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
University of Maryland Medical Center
Baltimore, MD 21201
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Johns Hopkins University School of Medicine
Baltimore, MD 21287
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Massachusetts General Hospital
Boston, MA 02114
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Corewell Health
Royal Oak, MI 48073
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Henry Ford Hospital
West Bloomfield, MI 48322
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Mayo Clinic - Rochester
Rochester, MN 55905
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Washington University
St Louis, MO 63110
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Albany Medical Center
Albany, NY 12208
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Montefiore Medical Center
The Bronx, NY 10467
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Duke University School of Medicine
Durham, NC 27710
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, NC 27401
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Sanford Fargo
Fargo, ND 58122
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, OH 45219
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Cleveland Clinic
Cleveland, OH 44195
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Ascension St. John Hospital
Tulsa, OK 74104
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
University of Pittsburgh Medical Center
Pittsburgh, PA 15213
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
OnSite Clinical Solutions, LLC - Rock Hill
Rock Hill, SC 29732
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
TriStar Centennial Medical Center
Nashville, TN 37203
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Vanderbilt University Medical Center
Nashville, TN 37232
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
St. David's Heart and Vascular dba Austin Heart - Main Office
Austin, TX 78705
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Houston Methodist Hospital
Houston, TX 77030
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, TX 75093
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Methodist Hospital - San Antonio
San Antonio, TX 78229
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
University of Utah Hospital & Clinics
Salt Lake City, UT 84112
Site contact: Kardigan Clinical Study Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
Study contacts (from the official record)
- Kardigan Clinical Trial Information Team · 1-877-310-5135 · clinicaltrials@kardigan.bio
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